evt_NCT00128856_v1_v2_3f2ff11a3655

{
  "changed_paths": [
    "/protocolSection/identificationModule/officialTitle",
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/startDateStruct/date",
    "/protocolSection/statusModule/startDateStruct/type",
    "/protocolSection/statusModule/completionDateStruct/date",
    "/protocolSection/statusModule/completionDateStruct/type",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/type",
    "/protocolSection/statusModule/primaryCompletionDateStruct",
    "/protocolSection/sponsorCollaboratorsModule/responsibleParty",
    "/protocolSection/designModule/designInfo/allocation",
    "/protocolSection/designModule/enrollmentInfo/count",
    "/protocolSection/designModule/enrollmentInfo/type",
    "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels",
    "/protocolSection/armsInterventionsModule/interventions/0/otherNames",
    "/protocolSection/armsInterventionsModule/interventions/1",
    "/protocolSection/armsInterventionsModule/interventions/1",
    "/protocolSection/armsInterventionsModule/armGroups",
    "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
    "/protocolSection/contactsLocationsModule/overallOfficials/0/name",
    "/protocolSection/contactsLocationsModule/overallOfficials/0/affiliation",
    "/protocolSection/contactsLocationsModule/overallOfficials/0/role",
    "/protocolSection/contactsLocationsModule/overallOfficials/1/name",
    "/protocolSection/contactsLocationsModule/overallOfficials/1/affiliation",
    "/protocolSection/contactsLocationsModule/overallOfficials/1/role",
    "/protocolSection/contactsLocationsModule/locations/0/facility",
    "/protocolSection/contactsLocationsModule/locations/0/city",
    "/protocolSection/contactsLocationsModule/locations/0/state",
    "/protocolSection/contactsLocationsModule/locations/0/zip",
    "/protocolSection/contactsLocationsModule/locations/0/geoPoint/lat",
    "/protocolSection/contactsLocationsModule/locations/0/geoPoint/lon",
    "/protocolSection/contactsLocationsModule/locations/1",
    "/protocolSection/contactsLocationsModule/locations/2",
    "/protocolSection/contactsLocationsModule/locations/3",
    "/protocolSection/contactsLocationsModule/locations/4",
    "/protocolSection/contactsLocationsModule/locations/5",
    "/protocolSection/contactsLocationsModule/locations/6",
    "/protocolSection/contactsLocationsModule/locations/7",
    "/protocolSection/contactsLocationsModule/locations/8",
    "/protocolSection/contactsLocationsModule/locations/9"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT00128856_v1_v2_3f2ff11a3655. ClinicalTrials.gov NCT00128856, versions 1-2. Evidence version 1.",
  "claims_not_supported": [
    "That the amendment was scientifically unjustified.",
    "That the change constitutes misconduct or wrongdoing.",
    "That sponsor intent can be inferred from this registry change.",
    "That the change caused or altered the trial's results.",
    "That the change was or was not disclosed in a manuscript.",
    "That TrialDiff determines regulatory compliance or non-compliance.",
    "That the outcome change was inconsistent with the protocol or statistical analysis plan.",
    "That event-class membership is a validated global review-priority ranking."
  ],
  "claims_supported": [
    "TrialDiff compared ClinicalTrials.gov record version 1 to version 2 for NCT00128856.",
    "The JSON Patch for this comparison has hash 4e5eeb2a90212d5be4f8dfb2785c94cb688713bf9d917373d76c58cc368312ac.",
    "The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.",
    "The deterministic triage label was critical; before timing adjustment it was critical.",
    "The triage label is uncalibrated metadata, not a validated review-priority finding.",
    "The patch satisfied these deterministic event-class predicates: primary_endpoint_changed_after_primary_completion_without_results_reconciliation.",
    "A registry field under the primary outcome module changed between ClinicalTrials.gov versions 1 and 2.",
    "The timing context for the from-version record was post_recruitment.",
    "The deterministic rules that fired were: arms_or_interventions_change, design_info_change, enrollment_count_change, primary_outcome_any_change, secondary_outcome_any_change.",
    "The changed JSON Pointer paths were: /protocolSection/identificationModule/officialTitle, /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/startDateStruct/date, /protocolSection/statusModule/startDateStruct/type, /protocolSection/statusModule/completionDateStruct/date, /protocolSection/statusModule/completionDateStruct/type, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/lastUpdatePostDateStruct/type, /protocolSection/statusModule/primaryCompletionDateStruct, /protocolSection/sponsorCollaboratorsModule/responsibleParty, /protocolSection/designModule/designInfo/allocation, /protocolSection/designModule/enrollmentInfo/count, /protocolSection/designModule/enrollmentInfo/type, /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels, /protocolSection/armsInterventionsModule/interventions/0/otherNames, /protocolSection/armsInterventionsModule/interventions/1, /protocolSection/armsInterventionsModule/interventions/1, /protocolSection/armsInterventionsModule/armGroups, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/3/description, /protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/4/description, /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/5/description, /protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame, /protocolSection/contactsLocationsModule/overallOfficials/0/name, /protocolSection/contactsLocationsModule/overallOfficials/0/affiliation, /protocolSection/contactsLocationsModule/overallOfficials/0/role, /protocolSection/contactsLocationsModule/overallOfficials/1/name, /protocolSection/contactsLocationsModule/overallOfficials/1/affiliation, /protocolSection/contactsLocationsModule/overallOfficials/1/role, /protocolSection/contactsLocationsModule/locations/0/facility, /protocolSection/contactsLocationsModule/locations/0/city, /protocolSection/contactsLocationsModule/locations/0/state, /protocolSection/contactsLocationsModule/locations/0/zip, /protocolSection/contactsLocationsModule/locations/0/geoPoint/lat, /protocolSection/contactsLocationsModule/locations/0/geoPoint/lon, /protocolSection/contactsLocationsModule/locations/1, /protocolSection/contactsLocationsModule/locations/2, /protocolSection/contactsLocationsModule/locations/3, /protocolSection/contactsLocationsModule/locations/4, /protocolSection/contactsLocationsModule/locations/5, /protocolSection/contactsLocationsModule/locations/6, /protocolSection/contactsLocationsModule/locations/7, /protocolSection/contactsLocationsModule/locations/8, /protocolSection/contactsLocationsModule/locations/9.",
    "The timeline value moved by 90 days.",
    "The timeline value moved by 3440 days.",
    "A timeline value changed and was classified by TrialDiff's timeline signal rules.",
    "A primary outcome definition field changed after primary completion between versions 1 and 2, without a results-posting co-occurrence signal."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
      "primary_outcome_change",
      "design_change",
      "arm_intervention_change",
      "secondary_outcome_change",
      "enrollment_change",
      "timeline_major_slip",
      "timeline_shift"
    ],
    "category": "primary_outcome_change",
    "deterministic_rules": [
      "arms_or_interventions_change",
      "design_info_change",
      "enrollment_count_change",
      "primary_outcome_any_change",
      "secondary_outcome_any_change"
    ],
    "event_class_rule_set_hash": "07957f8b90549d4f42387f51b471ecde9901b6db63bbc27b84c73631603407c0",
    "event_classes": [
      "primary_endpoint_changed_after_primary_completion_without_results_reconciliation"
    ],
    "rule_set_hash": "318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86",
    "severity": "critical",
    "severity_pre_timing": "critical",
    "timing_context": "post_recruitment",
    "triage_label": "critical",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
    "value_signals": [
      {
        "category": "timeline_shift",
        "date_struct": "startDateStruct",
        "delta_days": 90,
        "direction": "later",
        "new_precision": "month",
        "new_type": "ACTUAL",
        "new_value": "2003-03",
        "old_precision": "month",
        "old_type": null,
        "old_value": "2002-12",
        "path": "/protocolSection/statusModule/startDateStruct/date",
        "severity": "medium",
        "signal": "timeline_shift"
      },
      {
        "category": "timeline_major_slip",
        "date_struct": "completionDateStruct",
        "delta_days": 3440,
        "direction": "later",
        "new_precision": "month",
        "new_type": "ACTUAL",
        "new_value": "2015-01",
        "old_precision": "month",
        "old_type": null,
        "old_value": "2005-08",
        "path": "/protocolSection/statusModule/completionDateStruct/date",
        "severity": "high",
        "signal": "timeline_major_slip"
      },
      {
        "category": "timeline_shift",
        "date_struct": "primaryCompletionDateStruct",
        "direction": "unknown",
        "new_type": "ACTUAL",
        "new_value": "2015-01",
        "old_type": null,
        "old_value": null,
        "path": "/protocolSection/statusModule/primaryCompletionDateStruct",
        "reason": "date_unparsed_or_missing",
        "severity": "medium",
        "signal": "timeline_shift"
      }
    ]
  },
  "event_id": "evt_NCT00128856_v1_v2_3f2ff11a3655",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/identificationModule/officialTitle",
      "value": "Phase II Pharmacogenomic and Clinical Trial for the Administration of Gemcitabine-doxorubicin-paclitaxel (GAT) as Neoadjuvant Treatment of Patients With Stage III Breast Cancer"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2018-03"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/startDateStruct/date",
      "value": "2003-03"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/startDateStruct/type",
      "value": "ACTUAL"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/completionDateStruct/date",
      "value": "2015-01"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/completionDateStruct/type",
      "value": "ACTUAL"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2018-03-15"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2018-03-19"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/type",
      "value": "ACTUAL"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/primaryCompletionDateStruct",
      "value": {
        "date": "2015-01",
        "type": "ACTUAL"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/sponsorCollaboratorsModule/responsibleParty",
      "value": {
        "type": "SPONSOR"
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/designModule/designInfo/allocation",
      "value": "NA"
    },
    {
      "op": "replace",
      "path": "/protocolSection/designModule/enrollmentInfo/count",
      "value": 46
    },
    {
      "op": "add",
      "path": "/protocolSection/designModule/enrollmentInfo/type",
      "value": "ACTUAL"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels",
      "value": [
        "Gemcitabine + Adriamycine + Paclitaxel"
      ]
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames",
      "value": [
        "doxorubicin",
        "Paclitaxel"
      ]
    },
    {
      "op": "remove",
      "path": "/protocolSection/armsInterventionsModule/interventions/1"
    },
    {
      "op": "remove",
      "path": "/protocolSection/armsInterventionsModule/interventions/1"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/armGroups",
      "value": [
        {
          "description": "Neoadjuvant chemotherapy consisted of adriamycine 40 mg/m2, administered on day 1 as an i.v.\ninfusion.\nPaclitaxel 150 mg/m2 was administered on day 2 as an i.v infusión followed by gemcitabine 2000 mg/m2 as an i.v.\ninfusion.\nThe three drugs were administered every two weeks for 6 cycles.",
          "interventionNames": [
            "Drug: gemcitabine"
          ],
          "label": "Gemcitabine + Adriamycine + Paclitaxel",
          "type": "EXPERIMENTAL"
        }
      ]
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
      "value": "To determine the pathological response after surgery, based on the proportion of remaining tumor and post-chemotherapy changes, evaluating separately the response in the breast and in the axila lymph nodes."
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
      "value": "up to 5 months from last patient included"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
      "value": "It is evaluated by measuring the target lesions before and after treatment."
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
      "value": "up to 3 months from last patient included"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
      "value": "Conservative surgery rate versus other sugery"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
      "value": "up to 5 months from last patient included"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
      "value": "According to the criteria CTC version 2.0"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
      "value": "up to 6 months from last patient included"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
      "value": "Time from the start of treatment to the progression of the disease (if it happens)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
      "value": "5 years since surgery of last patient included"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
      "value": "Evaluation of changes in the tumor marker profile before and after treatment"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
      "value": "3 years"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
      "value": "Evaluation of changes in the tumor before and after treatment"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
      "value": "3 years"
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/overallOfficials/0/name",
      "value": "Study Director"
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/overallOfficials/0/affiliation",
      "value": "Hospital Miguel Servet"
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/overallOfficials/0/role",
      "value": "STUDY_DIRECTOR"
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/overallOfficials/1/name",
      "value": "Study Director"
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/overallOfficials/1/affiliation",
      "value": "Complejo Hospitalrio de Jaén"
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/overallOfficials/1/role",
      "value": "STUDY_DIRECTOR"
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/locations/0/facility",
      "value": "Hospital Universitario Germans Trias i Pujol"
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/locations/0/city",
      "value": "Badalona"
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/locations/0/state",
      "value": "Barcelona"
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/locations/0/zip",
      "value": "08916"
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/locations/0/geoPoint/lat",
      "value": 41.45004
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/locations/0/geoPoint/lon",
      "value": 2.24741
    },
    {
      "op": "add",
      "path": "/protocolSection/contactsLocationsModule/locations/1",
      "value": {
        "city": "Santander",
        "country": "Spain",
        "facility": "Hospital Universitario Marqués de Valdecilla",
        "geoPoint": {
          "lat": 43.46589,
          "lon": -3.80493
        },
        "state": "Cantabria",
        "zip": "39008"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/contactsLocationsModule/locations/2",
      "value": {
        "city": "Alcorcón",
        "country": "Spain",
        "facility": "Hospital Universitario Fundación Alcorcón",
        "geoPoint": {
          "lat": 40.34582,
          "lon": -3.82487
        },
        "state": "Madrid",
        "zip": "28922"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/contactsLocationsModule/locations/3",
      "value": {
        "city": "A Coruña",
        "country": "Spain",
        "facility": "Complejo Hospitalario Unviesitario A Coruña",
        "geoPoint": {
          "lat": 43.37135,
          "lon": -8.396
        },
        "zip": "15006"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/contactsLocationsModule/locations/4",
      "value": {
        "city": "Badajoz",
        "country": "Spain",
        "facility": "Hospital Infanta Cristina",
        "geoPoint": {
          "lat": 38.87789,
          "lon": -6.97061
        },
        "zip": "06080"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/contactsLocationsModule/locations/5",
      "value": {
        "city": "Jaén",
        "country": "Spain",
        "facility": "Complejo Hospitalario de Jaén",
        "geoPoint": {
          "lat": 37.76922,
          "lon": -3.79028
        },
        "zip": "23007"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/contactsLocationsModule/locations/6",
      "value": {
        "city": "Madrid",
        "country": "Spain",
        "facility": "Hospital Universitario La Princesa",
        "geoPoint": {
          "lat": 40.4165,
          "lon": -3.70256
        },
        "zip": "28006"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/contactsLocationsModule/locations/7",
      "value": {
        "city": "Madrid",
        "country": "Spain",
        "facility": "Hospital Universitario Ramón y Cajal",
        "geoPoint": {
          "lat": 40.4165,
          "lon": -3.70256
        },
        "zip": "28034"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/contactsLocationsModule/locations/8",
      "value": {
        "city": "Valencia",
        "country": "Spain",
        "facility": "Hospital General Universitario de Valencia",
        "geoPoint": {
          "lat": 39.47391,
          "lon": -0.37966
        },
        "zip": "46014"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/contactsLocationsModule/locations/9",
      "value": {
        "city": "Zaragoza",
        "country": "Spain",
        "facility": "Hospital Universitario Miguel Servet",
        "geoPoint": {
          "lat": 41.65606,
          "lon": -0.87734
        },
        "zip": "50009"
      }
    }
  ],
  "provenance": {
    "from_snapshot_hash": "377670fc9af8d5fb679baebbd6cf7af6e8833fd879a25b29f0d37798fc1c12a4",
    "materiality_event_hash": "39dba825c9220fc90353cef50d785ca7a43bacfa14d3c182b04f49975f356489",
    "patch_hash": "4e5eeb2a90212d5be4f8dfb2785c94cb688713bf9d917373d76c58cc368312ac",
    "patch_raw_hash": "1dc67e101d5037d3f9c21069b453565f955f74e88319f05131d5a59fe86fcd7c",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT00128856/history/1?patchToVersion=2",
    "to_snapshot_hash": "760ce615ba133d181ac175f8d61006e9a664152d60908829283bf834f776ca20"
  },
  "review_question": "What did the primary outcome field say before and after the amendment, and is there a public protocol, statistical analysis plan, or manuscript explaining the change?",
  "schema": "trialdiff.evidence_record",
  "trial": {
    "clinicaltrials_gov_url": "https://clinicaltrials.gov/study/NCT00128856",
    "nct_id": "NCT00128856"
  },
  "versions": {
    "from_version": 1,
    "submitted_date": "2018-03-15",
    "to_version": 2
  }
}